Serotonin (Solution) Instructions for Use
ATC Codes
A03FA (Gastrointestinal motility stimulants)
B02BX (Other systemic hemostatics)
Active Substance
Serotonin
Clinical-Pharmacological Group
Hemostatic agent
Pharmacotherapeutic Group
Hemostatic, serotonergic agent
Pharmacological Action
Hemostatic and serotonergic agent.
The hemostatic effect is due to its ability to increase platelet aggregation and capillary resistance, as well as to reduce bleeding time. Serotonin causes vasoconstriction of the kidneys and has an antidiuretic effect. It binds to serotonin receptors of the smooth muscles of internal organs and normalizes their contractile activity (endogenous vasomotion, peristalsis). The manifestation of the normalization of smooth muscle function is the stabilization of hemodynamics, restoration of the motor-evacuation function of the gastrointestinal tract, and reduction of local hypoxia.
Pharmacokinetics
After IV or IM administration, it is rapidly distributed throughout organs and tissues, remaining in the plasma for 8 hours. After IM administration, Cmax in plasma is reached within 0.5-1 hour. It is metabolized by deamination. It does not have a cumulative effect.
Indications
Functional intestinal obstruction; hemorrhagic syndrome: in Werlhof’s disease, during treatment with cytostatics, in acute, subacute and chronic radiation sickness, in malignant neoplasms; hypo- and aplastic anemia; thrombocytopenia; hemorrhagic vasculitis.
ICD codes
| ICD-10 code | Indication |
| D61 | Other aplastic anemias |
| D69.0 | Allergic purpura |
| D69.3 | Idiopathic thrombocytopenic purpura |
| D69.5 | Secondary thrombocytopenia |
| K56.6 | Other and unspecified intestinal obstruction |
| T66 | Unspecified effects of radiation (radiation sickness) |
| Y43.1 | Antineoplastic antimetabolites |
| Y43.3 | Other antineoplastic drugs |
| ICD-11 code | Indication |
| 3A70.Z | Aplastic anemia, unspecified |
| 3B64.1 | Acquired thrombocytopenia |
| 3B64.10 | Immune thrombocytopenic purpura |
| 3B64.11 | Secondary thrombocytopenia |
| 3B64.12 | Drug-induced thrombocytopenic purpura |
| 3B64.13 | Alloimmune thrombocytopenia |
| 4A44.92 | IgA vasculitis |
| 4A85.02 | Drug-induced cytopenia |
| 4A85.03 | Drug-induced vasculitis |
| 8E61.0 | Radiation-induced brain injury |
| 8E61.1 | Radiation-induced spinal cord injury |
| DA91.Z | Unspecified obstruction of small intestine |
| DB30.Z | Unspecified obstruction of large intestine |
| DE2Z | Diseases of the digestive system, unspecified |
| NF00 | Exposure to radiation, not elsewhere classified |
| PL00 | Drugs, medicaments or biological substances causing injury or harm in therapeutic use |
Dosage Regimen
| The method of application and dosage regimen for a specific drug depend on its form of release and other factors. The optimal dosage regimen is determined by the doctor. It is necessary to strictly adhere to the compliance of the dosage form of a specific drug with the indications for use and dosage regimen. |
Administer the solution by intramuscular (IM) or intravenous (IV) injection.
Determine the dosage individually based on the specific indication, clinical severity, and patient characteristics.
For hemostatic indications, including thrombocytopenia and hemorrhagic vasculitis, administer 5 mg to 10 mg daily.
For the management of functional intestinal obstruction, administer 5 mg to 20 mg daily.
Divide the total daily dose into two separate administrations.
Adjust the treatment duration based on the therapeutic effect achieved and the patient’s tolerance.
For IV administration, dilute the required dose in 100 ml to 200 ml of 0.9% sodium chloride solution.
Infuse the IV solution slowly, at a rate of approximately 20 to 30 drops per minute.
Avoid rapid intravenous injection to prevent pain along the vein and cardiovascular reactions.
If adverse reactions occur during infusion, stop administration for 2-3 minutes, then resume at a slower rate.
Do not administer concomitantly with calcium chloride preparations.
Adverse Reactions
From the urinary system: decreased diuresis.
From the digestive system: abdominal pain, nausea, diarrhea.
From the respiratory system: difficulty breathing.
From the cardiovascular system: cardialgia, increased BP.
Local reactions: pain along the vein (with rapid administration), with IM administration – pain at the injection site.
Contraindications
Hypersensitivity to serotonin adipinate; glomerulonephritis (acute and chronic); severe renal impairment (oligo- and anuria); arterial hypertension (including hypertensive crisis); acute thrombosis of arteries and veins; angioneurotic edema; bronchial asthma; diseases accompanied by hypercoagulation; pregnancy; childhood.
With caution
Patients with diseases of the cardiovascular system.
Use in Pregnancy and Lactation
Contraindicated for use during pregnancy.
Breastfeeding is not a contraindication for use.
Use in Renal Impairment
Use is contraindicated in patients with kidney disease.
Pediatric Use
Use is contraindicated in childhood.
Special Precautions
Do not administer with calcium chloride preparations.
If adverse reactions develop, it is recommended to stop the administration for 2-3 minutes, then continue administration at a slower rate.
Drug Interactions
Do not administer with calcium chloride preparations!
Serotonin potentiates the effect of narcotic, hypnotic, and analgesic drugs.
Diosmin, when used concomitantly, enhances the vasoconstrictive effect of serotonin.
Storage Conditions
Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.
Dispensing Status
Rx Only
Important Safety Information
This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.
Medical DisclaimerBrand (or Active Substance), Marketing Authorisation Holder, Dosage Form
Solution for intravenous and intramuscular administration 10 mg/1 ml: amp. 5 pcs.
Marketing Authorization Holder
Pharmashchita SPC, SE (Russia)
Dosage Form
| Serotonin | Solution for intravenous and intramuscular administration 10 mg/1 ml: amp. 5 pcs. |
Dosage Form, Packaging, and Composition
| Solution for IV and IM administration | 1 ml |
| Serotonin adipinate | 10 mg |
1 ml – ampoules (5) – trays (1) – cardboard packs.
Solution for intravenous and intramuscular injection 10 mg/1 ml: amp. 1 ml 5 or 10 pcs.
Marketing Authorization Holder
Lorr+K, LLC (Russia)
Manufactured By
Academician E.I. Chazov NMRC Of Cardiology Of The Ministry Of Health Of The Russian Federation, FSBI (Russia)
Dosage Form
| Serotonin adipate | Solution for intravenous and intramuscular injection 10 mg/1 ml: amp. 1 ml 5 or 10 pcs. |
Dosage Form, Packaging, and Composition
Solution for IV and IM administration in the form of a transparent, colorless or slightly colored liquid with a faint smell of hydrogen sulfide.
| 1 amp. (1 ml) | |
| Serotonin adipinate | 10 mg |
Excipients : sodium dimercaptopropanesulfonate (unitiol) – 1.5 mg, water for injection – up to 1 ml.
1 ml – ampoules of colorless glass (5) – contour cell packs (1) – cardboard packs.
1 ml – ampoules of colorless glass (5) – contour cell packs (2) – cardboard packs.
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